Phase 2 Kidney Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with urothelial carcinoma (a type of cancer affecting the lining of the kidney's collecting system, ureter, bladder, or urethra) confirmed by laboratory analysis of tissue or cells, where the cancer cannot be fully removed by surgery or has come back after treatment (the diagnosis must not be from an area that has received palliative radiation).
• People who have not yet received any treatment for their cancer in its unresectable or recurrent form.
• People whose cancer can be measured on a CT scan using a standard measurement system called RECIST version 1.1.
• People who are in good enough general health (rated 0 or 1 on a standard scale called ECOG Performance Status) and are able to swallow and take oral (by mouth) medication.
• People who are expected to survive for at least 12 weeks from the point of joining the trial.
• People whose blood and organ function test results at the screening stage meet all of the following levels: neutrophil count of at least 1,500/uL; platelet count of at least 100,000/uL; haemoglobin of at least 9.0 g/dL (with no red blood cell transfusion in the 14 days before the screening test); bilirubin no more than 1.5 times the upper normal limit (or below 3.0 mg/dL for people with a condition called Gilbert syndrome); liver enzymes (AST and ALT) no more than 3 times the upper normal limit; and kidney clearance rate (CrCl) of at least 50 mL/min.
• People aged 18 to 79 years at the time of giving consent, regardless of sex.
• Female patients who are capable of becoming pregnant and who are able to use contraception for 30 days before joining and for 2 years after finishing treatment with the study drug AM80.
• Male patients whose partners are capable of becoming pregnant, and who are able to use contraception from the start of AM80 treatment until 7 months after finishing, and to refrain from donating sperm during that period.
• People who have been fully informed about the trial and have voluntarily given written consent to participate.

Who may not be able to join:

• People who have previously been treated with certain immune checkpoint drugs — specifically those that target PD-1, PD-L1, PD-L2, CTLA-4, OX-40, or CD137.
• People who have received any of the following prior treatments for their urothelial carcinoma: a course of perioperative (around-the-time-of-surgery) therapy that finished less than 12 months before joining; intravesical therapy (treatment delivered directly into the bladder) within 28 days before joining; or palliative radiation to measurable cancer lesions within 14 days before joining.
• People who have not yet recovered from side effects of prior treatment (side effects need to have reduced to a mild or baseline level, except that mild-to-moderate fatigue and hair loss are permitted).
• People who have taken part in another clinical trial within 28 days before joining, or who received a trial drug or substance within the last 28 days (exceptions may apply if the trial drug was similar to an approved treatment — confirm with trial site).
• People who have cancer that has spread to the brain or spinal fluid, or who have a history of cancer spreading to the membranes around the brain or spinal cord.
• People who have had another type of cancer within the past 3 years, with some exceptions for certain cancers that have been fully treated and are considered cured (such as some skin cancers, early-stage cervical abnormalities, localised prostate cancer, or certain gastrointestinal cancers removed by endoscopy — confirm with trial site).
• People who are currently taking vitamin A supplements or any supplement containing vitamin A.
• People who have had surgery under general anaesthetic (other than a diagnostic biopsy) or a serious injury within 28 days before joining.
• People known to have a tendency to bleed or a clotting disorder, including those with significant bleeding within a tumour, a history of blood clots or bleeding disorders, or those who need to take blood-thinning or anti-platelet medications.
• People who have an active infection currently being treated with antibiotics, antifungal, or antiviral medications.
• People who test positive for hepatitis B surface antigen, hepatitis C virus antibody and RNA, or HIV antigen or antibody (people who test negative for hepatitis B surface antigen but positive for other hepatitis B markers may still be considered — this requires discussion with a specialist and the trial site).
• People who have a history of, or currently have, a lung condition called interstitial lung disease that is visible on imaging, or who have active non-infectious inflammation of the lungs.
• People who have an autoimmune disease, a history of chronic or recurring autoimmune disease, or who have needed high doses of steroid or immune-suppressing medications within 14 days before joining.
• People who are currently being treated for tuberculosis.
• People who have symptoms or signs of a blocked bowel requiring intravenous nutrition, or who have risk factors for a bowel perforation (such as acute diverticulitis, an abscess in the abdomen, bowel obstruction, or a history of abdominal tumours).
• People who have digestive system conditions that may affect how the body absorbs the study drug AM80.
• People who have had a serious allergic reaction or anaphylaxis to any component of the drugs used in this trial or to antibody-based treatments.
• People who have received a live or weakened (attenuated) vaccine within 30 days before joining.
• People who have serious complications affecting the liver, kidneys, heart, lungs, blood, or brain.
• People who have uncontrolled adrenal gland insufficiency, moderate or worse hearing loss (Grade 2 or higher), or moderate or worse nerve damage (Grade 2 or higher neuropathy).
• People who have excessively high levels of vitamin A in their body (hypervitaminosis A).
• People who are currently breastfeeding, unless they agree to stop breastfeeding for the duration of the study and for 6 months after the final dose of AM80.
• People who are pregnant or have a positive pregnancy test result.
• People who the lead investigator or trial doctor considers unsuitable for the trial for any other reason.

Important: Always verify eligibility with the trial site directly before applying.